510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Pharmacaribe LLC

Naples, FL, US

PHARMACARIBE LLC appears in FDA device records in Naples, FL. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
4
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 4 510(k) clearances for Pharmacaribe LLC between 2009 and 2013. The busiest year on record is 2010, with 2. The most recent is 2013, with 1.

Clearances by year, as a table
510(k) clearance decisions for Pharmacaribe LLC, by decision year
YearClearances
20091
20102
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K130091PULMOSALCAFSubstantially Equivalent
K101532NESSI OTC SPACERNVOSubstantially Equivalent
K101424PHARMACARIBE INHALED SALINE SOLUTIONSCAFSubstantially Equivalent
K091862NESSI SPACERNVOSubstantially Equivalent

Registered establishments

FDA registered establishments for Pharmacaribe LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30065006943006500694PHARMACARIBE LLC980 Palm View Drive #104, Naples, FL 34110 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0795-2016PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain